The present invention relates generally to a closure device for sealing a percutaneous puncture in a vessel, in particular a closure device with which haemostatic material is introduced in the incision channel leading to the puncture hole in the vessel wall, thereby sealing the percutaneous puncture without obstructing the flow inside the vessel and without the risk that the haemostatic material unintentionally is introduced into the vessel.
During certain types of medical surgery or treatment, an introducer is used to access the vascular system of a patient. The introducer is inserted through the wall of a blood vessel in order to obtain access to the vascular system and may thereafter be used for guiding medical instruments such as catheters, guide wires and the like. After the completion of the medical procedure, there will be an incision or a wound in the wall of the blood vessel corresponding to the size of the introducer. The bleeding from the wound, which is the result of such a surgical operation, may be stopped by applying direct pressure on the wound. However, applying external pressure on the wound will require assistance of additional medical personnel and may also obstruct the flow of blood through the vessel.
U.S. Pat. No. 4,744,364 and U.S. Pat. No. 4,852,568, both of which are granted to Kensey Nash Corp., disclose how a closure means can be inserted into a blood vessel and then retracted in such a way that the engagement surface of the closure means haemostatically engages the inner surface of the blood vessel contiguous with the puncture, thereby stopping the bleeding from the puncture wound. In U.S. Pat. No. 4,890,612, which is also granted to Kensey Nash Corp., a sealing device comprises a plug means having a holding portion to be positioned in engagement with the inner surface of a vessel and a sealing portion formed of a foam material that extends into the punctured vessel to engage tissue contiguous therewith to seal the puncture wound.
As is recognized in U.S. Pat. No. 6,368,341, which is granted to Abrahamson, a drawback with the types of sealing devices described in the above-mentioned U.S. Pat. Nos. 4,744,364, 4,852,568 and 4,890,612 is that an intra-arterial sealing device extending into a blood vessel may obstruct the flow of blood therethrough. The sealing device according to U.S. Pat. No. 6,368,341 comprises a haemostatic closure device and a locating device having one or several locating members to be positioned against the inner surface of the vessel wall. The locating members are designed to provide a sufficient amount of resistance against retracting movement, so that a user is provided with an indication that the locating members are in contact with the inner vessel wall. When correctly positioned, the haemostatic closure device, which may include a clotting agent, is in the incision channel outside the vessel wall and there are no portions extending into the vessel, where such portions may obstruct the flow of blood.